The latest data collected by the EU Commission shows that the current process for issuing a certification takes an average of approximately 18 months. This timeframe is not a conservative estimate, but rather a direct reflection of the operational reality characterizing the sector.

PROJECTION TOWARD 2027

Analyzing the calendar, the math leaves no room for interpretation: embarking on the certification journey at this moment means, in the best-case scenario, obtaining official approval by mid-2027.

Many manufacturers underestimate the preliminary stage of preparing technical files, which can require months even before the documentation is accepted by the Notified Body. A delay today translates into a concrete risk of market interruption tomorrow.

OVERCOMING THE DEADLINE BOTTLENECK

The invitation to all MD manufacturers is to act immediately. Submitting documentation now is the only effective strategy to avoid being trapped in the “bottleneck” that will inevitably form as regulatory deadlines approach. Reaching the deadline with the process still underway exposes the company to legal uncertainties and loss of market share.

A PROACTIVE APPROACH

Timeliness is not just about compliance; it is about business continuity. Acting ahead of time allows you to calmly manage any requests for additional documentation from auditors, transforming a bureaucratic obligation into a competitive advantage. Those who submit their dossiers today secure a priority position, ensuring a stable and secure presence for their medical devices on the European market.